Scandidos, Inc.
Madison, WI, US
SCANDIDOS, INC. appears in FDA device records in Madison, WI. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Scandidos, Inc. between 2006 and 2024. The busiest year on record is 2006, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223234 | Delta4 Insight | IYE | Substantially Equivalent | |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | IYE | Substantially Equivalent | |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ | IYE | Substantially Equivalent | |
| K151180 | ScandiDos Delta4 Phantom+ | IYE | Substantially Equivalent | |
| K052920 | DELTA4 | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007217656 | 3007217656 | SCANDIDOS, INC. | 7202 Countrywood Ln., Madison, WI 53719 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain